Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT02697292
Status:
TERMINATED
Last Update Posted:
2019-12-30
First Post:
2016-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'C558471', 'term': 'Hizentra'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Pittock.Sean@mayo.edu', 'phone': '507-2084-4741', 'title': 'Sean J. Pittock, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Seizure Frequency From Baseline to 5 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.'}, {'id': 'OG001', 'title': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '1.1', 'ciUpperLimit': '98.9', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 5 weeks', 'description': 'The number of subjects who experience a ≥ 50% reduction in seizure frequency', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.'}, {'id': 'OG001', 'title': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 5 weeks', 'description': 'Number of subjects who experienced stable or improved cognitive assessment. Cognitive status was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS is a individually administered standardized battery of 12 tests that measure cognitive decline or improvement taking approximately 30 minutes. Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score (range 40-160)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject did not complete the assessment at week 5 for the placebo arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.'}, {'id': 'FG001', 'title': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.'}, {'id': 'BG001', 'title': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '77'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '66', 'upperLimit': '77'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '59', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-09', 'size': 1220402, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-04T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2016-02-19', 'resultsFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-12', 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Seizure Frequency From Baseline to 5 Weeks', 'timeFrame': 'baseline, 5 weeks', 'description': 'The number of subjects who experience a ≥ 50% reduction in seizure frequency'}], 'secondaryOutcomes': [{'measure': 'Change in Cognitive Assessment', 'timeFrame': 'baseline, 5 weeks', 'description': 'Number of subjects who experienced stable or improved cognitive assessment. Cognitive status was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS is a individually administered standardized battery of 12 tests that measure cognitive decline or improvement taking approximately 30 minutes. Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score (range 40-160)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intravenous Immunoglobulin', 'VGKC', 'Autoimmune epilepsy', 'Gamumex-C'], 'conditions': ['Autoimmune Epilepsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials.', 'label': 'Mayo Clinic Clinical Trials'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Randomized+Placebo+Controlled+Trial+of+IVIG+in+autoimmune+LGI1%2FCASPR2+epilepsy', 'label': 'PubMed'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces significantly the number of epileptic seizures in cases of autoimmune epileptic seizures.', 'detailedDescription': 'The purpose of this study is to determine if intravenous immunoglobulin (IVIG) treatment significantly reduces the number of epileptic seizures in cases of autoimmune epilepsy. Potential participants will be screened at an outpatient neurology clinic visit appointment. Interested qualified potential participants will be consented and offered participation in this trial. Once consent has been obtained, and it is determined that the participant meets all inclusion criteria, the participant will be randomized to either IVIG or placebo treatment for the next 5 weeks. Participants will return to Mayo Clinic for an evaluation. Those participants that received the placebo for 5 weeks will be given IVIG in an open label fashion for 5 weeks (week 7-11) then return to Mayo Clinic for evaluation. All participants will receive monthly phone calls after they complete the IVIG treatment for a period of 1 year from the end of IVIG 5 week course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seropositivity for Voltage Gated Potassium Channel Complex (VGKC) complex antibodies or positive for Leucine-Rich, Glioma Inactivated 1 (LGI1)/contactin-associated protein-like 2 (CASPR2) Antibody by cell based assay.\n* And ≥ 2 seizures per week (mean of total over 1 week)\n* And duration of epilepsy \\<3 years\n* Male or female between the ages of 18 and 80 years of age\n* Women and men of child bearing potential must agree to use a reliable form of contraception throughout the course of the study.\n* Homecare treatment agency available at place of residence.\n\nExclusion Criteria:\n\n* History of thrombotic episodes within the 2 years prior to enrollment\n* Known allergic or other severe reactions to blood products including intolerability to previous IVIG\n* Immunoglobulin A (IgA) deficiency\n* Prior failed trial of high dose steroid (prednisone \\>60mg daily or methylprednisolone \\>1g weekly for \\>2 weeks)\n* Reproductive status:\n\n * Women who are pregnant,\n * Women who are breastfeeding,\n * Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator. (Women of non-childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for \\> 12 months prior to screen visit.)\n* Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.\n* Evidence of serious uncontrolled concomitant diseases that may preclude patient participation (physician determined), as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency\n* Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.\n* Evidence of chronic active hepatitis B or C.\n* Active ischemic heart disease in the past year prior to baseline.\n* Patients should not have severe renal or hepatic disease (determined by treating physician).\n* Severe hypertension'}, 'identificationModule': {'nctId': 'NCT02697292', 'briefTitle': 'IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy', 'orgStudyIdInfo': {'id': '15-005649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Normal Saline Group', 'description': 'Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.', 'interventionNames': ['Drug: Intravenous Immunoglobulin', 'Drug: Placebos', 'Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'description': 'Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.', 'interventionNames': ['Drug: Intravenous Immunoglobulin', 'Drug: Normal Saline']}], 'interventions': [{'name': 'Intravenous Immunoglobulin', 'type': 'DRUG', 'otherNames': ['Gamunex-C'], 'description': 'GAMUNEX-C is a clear a ready-to-use sterile solution of human immune globulin protein for intravenous administration. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day \\[week 1 day 1\\], then will receive 1g/kg not exceeding 80 grams daily for 1 day \\[week 1 day 2\\]. Then once every 2 weeks subjects will receive 0.6g/kg IVIG for 4 weeks \\[week 3 and 5\\] for 2 infusions.', 'armGroupLabels': ['Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'Placebo/Normal Saline Group']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Dose will be determined based on ideal wt. with not to exceed 80 grams. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day \\[week 1 day 1\\], then will receive 1g/kg not exceeding 80 grams daily for 1 day \\[week 1 day 2\\]. Then once every 2 weeks subjects will receive 0.6g/kg for 4 weeks \\[week 3 and 5\\] for 2 infusions.', 'armGroupLabels': ['Placebo/Normal Saline Group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Subjects will receive 500 ml normal saline before and after the higher dose infusion of 1g/kg', 'armGroupLabels': ['Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group', 'Placebo/Normal Saline Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Sean Pittock, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grifols Shared Services North America', 'class': 'UNKNOWN'}, {'name': 'Option Care', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sean Pittock', 'investigatorAffiliation': 'Mayo Clinic'}}}}